Transseptal (TS) access for left heart procedures is an important and rapidly growing space for diagnostics and therapy delivery with an expected total of over 10 million U.S. patients. In the U.S. and/or Europe, TS access procedures are used for atrial fibrillation (AF) ablation, left atrial appendage (LAA) closure, patent foramen ovale (PFO) closure, and treatment of mitral valve regurgitation (MR). For the latter, treatment of severe MR can be accomplished through TS access and the placement of a clip (MitraClip or MC) on the mitral valve. Catheter positioning for MC placement has been challenging even for the most experienced interventionalist cardiologists (ICs) and has led to long procedure times with significant x-ray exposure. The initial TS access entry point into the left side of the heart s the key factor for MC placement. TS access procedures have not significantly changed since early reports by Ross in 1959 ("drag and drop" technique) and many challenges still exist with this method including difficulty with: catheter localization, catheter stabilization, and the risk f atrial wall or aortic puncture. While the "drag and drop" technique provides an optimal inferior septal access point for ablation procedures, the MC procedure requires a more superior/posterior puncture site due to the multiple turns required by the catheter for final clip placement. While this superior/posterior position can be located with echocardiography, the constant movement of the heart and the thin and slippery nature of the fossa ovalis (FO) make standard TS access punctures unpredictable. Access that is too high or too low relative to the mitral valve can make implantation of the MC virtually impossible thus requiring device removal, TS re-puncture, and device re-advancement. Thus, initial localization on the FO with subsequent stabilization prior to and during TS access is critical for MC procedures to limit implant times and x-ray exposure. In this proposal, we will validate the ability of a novel, deflectable transseptal access catheter (TSAC) that utilizes vacuum suction technology to provide improved catheter localization and stabilization, easier puncture of the FO, and thus leading to decreased TS and MC procedural and x-ray exposure times. To accomplish this goal, we will assess both the safety and the ability of the TSAC to reduce procedure and x-ray exposure times for delivery of MC relative to traditional means for TS access in human cadavers with heart failure and in chronic heart failure swine with MR. This proposal addresses a clinically significant problem with applications that can reach beyond treatment of MR to multiple TS left heart procedures.
The ability to achieve adequate localization and stabilization of the left atrium during atrial transseptal puncture is important for numerous procedures, including the delivery of mitral clips for the treatment of mitral valve regurgitation. The purpose of this Phase I SBIR is to validate the ability of a novel, low profile suction catheter to provide safe and stable access across the atrial septum for decreased procedural and fluoroscopic exposure time and to improve therapy delivery.